A multi-centre randomized controlled trial investigating Consolidation Chemotherapy with and without oxaliplatin in distal rectal cancer and Watch & Wait.

Autor: Habr-Gama A; University of São Paulo School of Medicine, São Paulo, Brazil.; Angelita and Joaquim Gama Institute, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil.; Department of Coloproctology, Hospital Alemão Oswaldo Cruz, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil., São Julião GP; Angelita and Joaquim Gama Institute, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil.; Department of Coloproctology, Hospital Alemão Oswaldo Cruz, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil.; Department of Surgical Oncology, Hospital Beneficencia Portuguesa, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil., Ortega CD; Department of Radiology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil.; Department of Radiology and Diagnostic Imaging, Hospital Israelita Albert Einstein, São Paulo, Brazil., Vailati BB; Angelita and Joaquim Gama Institute, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil.; Department of Coloproctology, Hospital Alemão Oswaldo Cruz, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil.; Department of Surgical Oncology, Hospital Beneficencia Portuguesa, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil., Araujo S; Department of Radiology and Diagnostic Imaging, Hospital Israelita Albert Einstein, São Paulo, Brazil., Jorge T; Department of Medical Oncology, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil., Sabbaga J; Department of Medical Oncology, Hospital Sírio Libanês, São Paulo, Brazil., Rossi GL; Servicio Cirugia General, Hospital Italiano de Buenos Aires, Sector de Coloproctologia, Buenos Aires, Argentina., D'Alpino R; Centro Paulista de Oncologia, São Paulo, Brazil., Kater FR; Department of Medical Oncology, Hospital Beneficencia Portuguesa, São Paulo, Brazil., Aguilar PB; Department of Radiation Oncology, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil., Mattacheo A; Hospital Gral. J. M. Ramos Mejia, Buenos Aires, Argentina., Perez RO; Angelita and Joaquim Gama Institute, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil. rodrigo.operez@gmail.com.; Department of Coloproctology, Hospital Alemão Oswaldo Cruz, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil. rodrigo.operez@gmail.com.; Department of Surgical Oncology, Hospital Beneficencia Portuguesa, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil. rodrigo.operez@gmail.com.; Ludwig Institute for Cancer Research, Praça Amadeu Amaral, 47 - conj.111, São Paulo, 01327-904, Brazil. rodrigo.operez@gmail.com.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2023 Jun 14; Vol. 23 (1), pp. 546. Date of Electronic Publication: 2023 Jun 14.
DOI: 10.1186/s12885-023-10984-2
Abstrakt: Background: Neoadjuvant chemoradiation(nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait-WW). Consolidation chemotherapy(cCT) regimens using fluoropyrimidine-based with or without oxalipatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCT compared to fluoropirimidine alone regimens in terms of primary tumor response remains unclear. Since oxalipatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine + oxaliplatin) for patients with distal rectal cancer.
Methods: In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54 Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine + oxaliplatin. Magnetic resonance(MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1 cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy(RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) may be enrolled in an organ-preservation program(WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion. Secondary endpoints are 3-year surgery-free survival, TME-free survival, distant metastases-free survival, local regrowth-free survival and colostomy-free survival.
Discussion: Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation.
Trial Registration: www.
Clinicaltrials: gov NCT05000697; registered on August 11 th , 2021.
(© 2023. The Author(s).)
Databáze: MEDLINE
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